The present invention relates to the field of medical devices, in particular therapeutic vascular intervention devices requiring anchoring.
In the last few decades, therapeutic intervention in the cardiovascular arena has seen major advances in the reducing the invasiveness of life-saving procedures. In fact, coronary artery bypass has been surpassed, now, by coronary stenting in most patients with two or fewer lesions. Continuing this trend, several cardiovascular stents and valves have been designed to facilitate minimally invasive placement, frequently through the use of percutaneous catheter technologies.
While successful in several arenas, the minimally invasive placement of cardiovascular devices in areas of high flow or high stress has been relatively unsuccessful. This is due, in large part, to the migration of the devices after they have been placed but before they developed a firm attachment to the wall of the lumen. These issues are currently being seen in several percutaneous aortic valve technologies.
In an effort to combat the migration issue, several devices such as those found in Anduiza U.S. Pat. No. 6,875,231 and Anderson's U.S. Pat. Nos. 6,186,614, 5,840,081 and 5,411,552 are incorporating larger and larger support structures which span larger and larger sections of the lumen, causing issues related to side-branch obstruction and the requirement for anticoagulation. These devices also require a large degree of external pressure in the lumen in which they are anchored to be able to withstand the large migration-producing forces they face immediately post-implantation. Furthermore, these issues are also prevalent in percutaneous aortic aneurysm repair.
The current state of the art, then, would benefit from a minimally invasive method to firmly anchor cardiovascular and other types of devices in a low-profile, reversible manner using a minimum of hardware. The current invention provides this advance with a two-component procedure in which an anchoring element and an anchored device are placed in separate procedures. This two-part procedure allows for the anchoring element to be placed with enough lead time to allow for cellular ingrowth and firm anchoring prior to placement of the anchored device. Thus, before the device is attached, the physician will be able to visualize exactly where the device will be placed and the device will remain firmly in place once placed. After the anchoring element has been firmly embedded in the vascular wall, the anchored device (stent, valve, etc.) can be inserted and firmly attached to the anchoring element. The insertion of the device can also be accompanied by other interventions, ie native valve debridement. The present invention overcomes the limitations of the prior art by allowing for low-profile insertion into the lumen with a decreased risk of migration due to the presence of extensive tissue-ingrowth prior to exposing the anchored device to the migration-producing forces it will face immediately post-implantation.